A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Официальное название

A Phase 3, 24-week, Randomized, Double-blind, Parallel-group Bayesian Dynamic Borrowing Study Comparing the Efficacy, Safety, Tolerability and Pharmacokinetics of FF/UMEC/VI With FF/VI in 12-17-year-old Participants With Inadequately Controlled Asthma on Stable Maintenance Therapy With ICS/LABA

Обзор

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.

Вмешательства

• Препарат FF/UMEC/VI
  FF/UMEC/VI will be administered.
• Устройство ELLIPTA
  FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
• Препарат FF/VI
  FF/VI will be administered.

Первичные конечные точки

• Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 [Срок оценки: Baseline (Week 0) and Week 24]

Вторичные конечные точки (6)

• Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale) [Срок оценки: Baseline (Week 0) and Week 24]
• Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale) [Срок оценки: Baseline (Week 0) and Week 24]
• Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale) [Срок оценки: Baseline (Week 0) and Week 24]
• Number of Participants with a clinically important change from baseline in ACQ-7 Score [Срок оценки: Week 24]
• Number of Participants with a clinically important change from baseline in ACQ-6 Score [Срок оценки: Week 24]
• Number of Participants with a clinically important change from baseline in ACQ-5 Score [Срок оценки: Week 24]

Критерии участия

Критерии включения

• Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
• Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0.
• Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of >250 to <=500 microgram (mcg)/day fluticasone propionate, or equivalent).
• In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
• Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
• A best pre-bronchodilator FEV1 >40% to <=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.

Критерии исключения

• Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
• Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
• History of Life-threatening Asthma
• Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
• Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 26 центров

• GSK Investigational Site — Birmingham
• GSK Investigational Site — Mobile
• GSK Investigational Site — Paradise Valley
• GSK Investigational Site — Bakersfield
• GSK Investigational Site — Mission Viejo
• GSK Investigational Site — Rolling Hills Estates
• GSK Investigational Site — Colorado Springs
• GSK Investigational Site — Aventura
• … и ещё 18 центров

Аргентина · 14 центров

• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Córdoba
• GSK Investigational Site — Lanus
• GSK Investigational Site — Lobos
• … и ещё 6 центров

Израиль · 4 центра

• GSK Investigational Site — Ashkelon
• GSK Investigational Site — Haifa
• GSK Investigational Site — Haifa
• GSK Investigational Site — Petah Tikva

South Korea · 4 центра

• GSK Investigational Site — Cheongju Chungcheongbuk-do
• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul

Turkey (Türkiye) · 4 центра

• GSK Investigational Site — Adana
• GSK Investigational Site — Antalya
• GSK Investigational Site — Istanbul
• GSK Investigational Site — Istanbul

Австралия · 3 центра

• GSK Investigational Site — South Brisbane
• GSK Investigational Site — North Adelaide
• GSK Investigational Site — Joondalup WA

Чили · 3 центра

• GSK Investigational Site — Lo Barnechea
• GSK Investigational Site — Santiago
• GSK Investigational Site — Santiago

Мексика · 3 центра

• GSK Investigational Site — Guadalajara
• GSK Investigational Site — Monterrey
• GSK Investigational Site — San Juan del Río

Новая Зеландия · 1 центр

• GSK Investigational Site — Ebdentown

Идентификаторы

NCT: NCT05757102 · 206867

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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